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Lead Auditor

2 months ago

New York, United States X4 Life Sciences Full time

X4 Life Sciences' lead Notified Body client are looking to add a Lead Auditor for Non-Active Medical Devices to their team.

The Auditor performs third-party audits per certification procedures and the requirements of the applicable standard(s). They perform collection and analysis of sufficient information and provides with a recommendation for certification. The Auditor is responsible for making relevant decisions regarding certification audit and the audit process and informing knowledge on issues resolution outside the audit process.

Job Functions Perform certification audits in any capacity in conformance with the Global/Local procedures, sector specific schemes/standards, ensure that such duties are performed in an efficient and commercially expedient way. Upon evidence gained during audits, provides with determination whether or not registration should be recommended or allowed to continue. Assimilates, understands, and operates the Certification System in all auditing activities. Liaises with the Product Managers, Technical Accreditation Knowledge and Manager, Technical Accreditation Knowledge regarding changes to its design and implementation. Collaborates with teams of Auditors during the auditing activities. Strives to provide customers with sufficient audit experience to cover the whole of the client's certification's accredited activities. Assists in the training of other Auditors and Senior Auditors during planned audits or during other training functions. Actively participates in witness audits by the client or accreditation bodies. Maintains all audit-related credentials. Undertake any other activities as directed by the Manager, Certification Audit Knowledge or Manager, Technical Accreditation Knowledge. Adheres to internal standards, policies, and procedures. Performs other duties as assigned.

Qualifications Education and Experience Bachelor’s degree in a related discipline (i.e., Engineering, Food Science, etc.) AND (Required) Minimum 3-5 years of related experience (Required)

Licenses and Certifications Certifications necessary based on the schemes/standards needed for the business sector. (Required)

Knowledge, Skills and Abilities Strong background and knowledge of technical applications of the standards Excellent communication and interpersonal, verbal, written and presentation skills Proactive attitude and excellent organizational skills Effectively reacts in stressful situations and make clear, well-founded decisions regarding conformity during the audit Ability to multitask and manage multiple projects while delivering results on time Act with integrity, tact and character

Computer Skills MS Office Suite (Word, Excel, PowerPoint) – Intermediate user proficiency

Interviews are taking place this week, so please apply within if interested.

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